Transvaginal Mesh Laws
The surgical implantation of a transvaginal mesh product to help with Pelvic Organ Prolapse (POP) has been linked to serious complications affecting women across the country. Separate or combined lawsuits can be brought against the companies that are allegedly responsible for these defective products which have been causing severe side effects that can be life altering to women. This type of lawsuit is covered in Tort Law. Tort is defined by Cornell Law as “civil wrongs recognized by law.” These wrongs have an ending result in injury or harm and constitute the basis for a claim by the injured party. While some torts are punishable crimes and can lead to imprisonment, the primary aim of tort law is to provide relief for the damages incurred and deter others from committing the same harms. The individual who sustains injury or suffers pecuniary damage (transvaginal mesh users) as the result of tortious conduct is known as the plaintiff, and the person who is responsible for inflicting the injury and incurs liability for the damage is known as the defendant or tortfeasor (manufacturers of transvaginal mesh). The most common manufacturers of transvaginal mesh products include:
- C.R. Bard
- Boston Scientific Corporation
- American Medical Systems
- Ethicon, Inc., a subsidiary of Johnson and Johnson
There are four categories of torts: intentional torts, negligent torts, strict liability, and product liability torts. Transvaginal mesh falls under product liability torts. Three elements must be established in every tort action. These are:
- The plaintiff must establish the defendant was under a legal duty to act in a particular fashion.
- The plaintiff must demonstrate the defendant breached this duty by failing to conform his or her behavior accordingly.
- The plaintiff must prove he/she suffered injury or loss as a direct result of the defendant’s breach.
Hundreds of thousands of women have had the transvaginal mesh implants. Complications from the product’s side effects were quickly being made to the FDA from multiple surgeries performed between 2005-2010. An FDA advisory panel came together to discuss the safety of medical drugs and devices, including transvaginal mesh, and recommended tougher premarket testing of vaginal mesh products and the reclassification of the devices to a Class III—the highest-risk category for medical devices—without recalling existing products. However, after a few months of testing it became very clear that the product was faulty and complications from the product could be very severe for women using the mesh. 15 percent of the women implanted with the mesh suffered within a period of three months from vaginal mesh erosion. In 2008, the FDA warned doctors who were performing the surgery, that numerous negative reports and complications had been received. The FDA informed doctors they should be warning patients of the complications associated with the implantation of the transvaginal mesh. Even after this caution letter, the number of complaints associated with transvaginal mesh implants were still rising (have been) and more and more women were being treated for complications. Unfortunately, even after removal of the mesh, women still have had damaging side effects. If you are suffering from the complications of a transvaginal mesh implant, seeking the assistance of Christensen & Hymas by calling (801)506-0800 today could help you get the compensation you deserve for the pain and suffering you have endured from these manufacturers and their faulty product.
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